The GMP Manufacturing Operations Manager will be responsible for supervising manufacturing operations staff and partnering with project planning to plan and supervise the activities of Vernal Biosciences’ CGMP manufacturing operation. In addition to being fully trained in production processes, the incumbent will take a hands-on approach to ensure that manufacturing operations are performed in strict compliance with current Good Manufacturing Practices (CGMP), environmental health and safety (EHS) guidelines, and any other regulations that may apply. Additionally, the Operations Manager will perform actual manufacturing procedures, assist with technical transfer, and process room setup; lead process training, room changeovers, and equipment requalification; manage batch records and investigations. Due to the production schedule, the work schedule for this position will vary from month to month but is generally during the first shift (0800-1630 hours).

Key Areas of Focus

• Execute and plan activities related to production planning for drug substance and drug product manufacturing.
• Uses Vernal’s quality systems and programs to promote high-quality standards and continuous quality improvement as it relates to manufacturing operations.
• Ensures compliance with FDA Current Good Manufacturing Practices (CGMP), EU, and ICH guidelines and regulations and leads as SME to cross-functional groups within Vernal.
• Ensures manufacturing documentation is compliant with Vernal policies and other applicable regulatory guidelines.
• Train manufacturing personnel on Vernal’s SOPs to ensure appropriate codification of GLP/GMP procedures relating to manufacturing operations.

Essential Duties and Responsibilities

• Follow and review batch records, SOPs, and work instructions to ensure compliance with operations.
• Manufacturing of commercial, clinical, and development drug products on the Vernal mRNA platform
• Train, supervise, and review the performance of all manufacturing operators
• Train and assist manufacturing operations personnel on set up, Disassembly, and Operation of process equipment.
• In-process cleaning of equipment and process rooms
• Cleaning of fixed process equipment in process rooms
• Upstream and downstream manufacturing operations as it relates to Vernal’s process for GMP manufacturing of mRNA drug substances and drug products.
• Interface with relevant cross-functional groups necessary for the operation and maintenance of the facility and manufacturing of drug product

Professional Experience and Qualifications

• Bachelor’s degree is ideally focused in a scientific, technical, or engineering discipline or the equivalent combination of education and experience.
• Bachelor’s degree and at least 5 years of relevant experience or the equivalent combination of education and experience (High School degree with 6 years of experience or associate degree with 4 years of experience)
• Ability to lift up to 50 lbs., visual acuity, manual dexterity, and ability to distinguish between the colors red, yellow, blue, and green.
• Knowledge of CGMP requirements for manufacturing as well as equipment and cleaning activities.
• Solid organizational, interpersonal, communication, and documentation skills.
• Ability to follow written and oral instructions in English.
• Basic computer skills and ability to learn new systems.
• Ability to escalate any issues related to manufacturing and any that may impact project timelines and deliverables.

Diversity/Equal Opportunity

Vernal is an equal opportunity employer. We recognize the value of diverse, multifaceted approaches towards innovation and aim to incorporate diverse perspectives and experiences. We strive to build a safe, welcoming, and inclusive work culture.

At Vernal, you will offer knowledge-based solutions to help us address the growing demand for mRNA, lipid nanoparticle (LNP) mRNA, drug screening, and ultimately clinical supply of mRNA. Together, we will create the most integrated solution for mRNA vaccines and therapeutic R&D. Vernal will become the only one-stop-shop for our clients’ and partners’ mRNA needs, from concept all the way to clinical trials. The mRNA research associate or scientist will develop methods to synthesize, purify, and scale up mRNA. As a startup, we are seeking adaptable, creative thinkers who can independently foresee gaps and opportunities and who take the initiative to solve problems with a sense of urgency. We expect the work to be rewarding, fast-paced, and to offer ample opportunities to plan and create new solutions to help grow our business. Vernal will pay a competitive salary with generous benefits including health, dental, and vision insurance. Although hiring level will depend on experience, we expect to grow with our employees and are interested in a variety of backgrounds.

Vernal Biosciences is located in Colchester, Vermont, adjacent to Burlington which is home of the University of Vermont and the UVM Medical Center. Check out https://www.helloburlingtonvt.com/ for more information. The Burlington area, set on the shores of Lake Champlain, features the best of two worlds:

Please contact careers@vernal.bio with CVs or for more information putting the job title in the subject line